Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery: A Randomized Three-Arm Controlled Trial

Abstract

Objective Transnasal skull base surgery is a complex and invasive procedure that involves the use of preoperative antiseptic preparations. However, evidence supporting their use in preventing postoperative infectious complications is limited. The aim of this study is to assess the efficacy of preoperative antiseptic techniques in reducing postoperative infectious complications within 30 days of surgery.

Methods A multicenter, prospective, randomized, single-blind, three-arm trial was conducted from February 2019 to October 2021. Participants were randomized to either of three antiseptic preparation techniques: external 0.9% NaCl nasal preparation, external 0.05% chlorhexidine gluconate, or intranasal irrigation with 80 mg of gentamicin added to 1,000 mL of 0.9% NaCl plus external nasal preparation with chlorhexidine gluconate 0.05%. A total of 130 adults with skull base pathologies were randomized; 12 were excluded before randomization for failure to meet the inclusion criteria (n = 9) or refusal to participate (n = 3). We excluded patients with evidence of infection adjacent to the surgical site, allergies to preparation methods, those who underwent craniotomy during the same admission, and pediatric patients.

Results The mean age of the participants was 43.26 ± 14.45 years. Nine patients developed postoperative infections (meningitis, n = 8; sinusitis, n = 2). Among the factors studied, length of surgery (p = 0.002), perioperative cerebrospinal fluid (CSF) diversion (p = 0.01), chordoma (p = 0.004), extended approach (p = 0.026), and postoperative CSF leak (p = 0.025) were significantly associated with postoperative infections. There were no clinically meaningful or significant differences in the studied intervention groups regarding postoperative infectious complications.

Conclusion Preoperative antiseptic techniques failed to prefer one application to prevent postoperative infectious complications in patients who underwent endoscopic transnasal skull base surgery.

Keywords

antisepsis - skull base - sinusitis - meningitis

Data Availability

Data of the current original research are available from the corresponding author on reasonable request.

Authors' Contributions

Conceptualization was done by A.Aj. and Saa.A. Data curation was done by A.Ala., S.B.A., As.A., S.B., G.A., A.Alq., Sau.A., A.S.A., and Gh.A. Formal analysis, external analysis, and funding acquisition were done by A.Aj. and A.Ala. Investigation was done by M.B., A.Alo., F.F., and F.A.F. Methodology was developed by A.Aj., M.B., Saa.A., F.F., A.Ala., and Ah.A. Project administration was done by As.A., B.M.N.E., F.A.F. Resources were managed by F.F., O.A., A.Ala., and L.A. Software was managed by A.Ala. and S.B.A., and A.Aj. and Saa.A supervised the study. A.Ala., A.Aj., S.B., As.A., and S.B.A. wrote the original draft of the manuscript. All the authors read and approved the final manuscript.

Ethical Approval

This study was approved by our Institutional Ethics Review Board (E-18-3331).

Publication History

Received: 17 May 2024

Accepted: 06 October 2024

Accepted Manuscript online:
08 October 2024

Article published online:
28 October 2024

• References

• 1 Cappabianca P, Cavallo LM, Colao A, de Divitiis E. Surgical complications associated with the endoscopic endonasal transsphenoidal approach for pituitary adenomas. J Neurosurg 2002; 97 (02) 293-298
• 2 Kassam AB, Prevedello DM, Carrau RL. et al. Endoscopic endonasal skull base surgery: analysis of complications in the authors' initial 800 patients. J Neurosurg 2011; 114 (06) 1544-1568
• 3 Lee SJ, Cohen J, Chan J, Walgama E, Wu A, Mamelak AN. Infectious complications of expanded endoscopic transsphenoidal surgery: a retrospective cohort analysis of 100 cases. J Neurol Surg B Skull Base 2020; 81 (05) 497-504
• 4 Kono Y, Prevedello DM, Snyderman CH. et al. One thousand endoscopic skull base surgical procedures demystifying the infection potential: incidence and description of postoperative meningitis and brain abscesses. Infect Control Hosp Epidemiol 2011; 32 (01) 77-83
• 5 World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection. World Health Organization; Geneva: 2018
• 6 Smith EJ, Stringer S. Current perioperative practice patterns for minimizing surgical site infection during rhinologic procedures. Int Forum Allergy Rhinol 2014; 4 (12) 1002-1007
• 7 Schulz KF, Altman DG, Moher D, Group C. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg 2011; 9 (08) 672-677
• 8 Fokkens WJ, Lund VJ, Hopkins C. et al. European position paper on rhinosinusitis and nasal polyps 2020. Rhinology 2020; 58 (Suppl S29): 1-464
• 9 Christian E, Harris B, Wrobel B, Zada G. Endoscopic endonasal transsphenoidal surgery: implementation of an operative and perioperative checklist. Neurosurg Focus 2014; 37 (04) E1
• 10 Laws ER, Wong JM, Smith TR. et al. A checklist for endonasal transsphenoidal anterior skull base surgery. J Neurosurg 2016; 124 (06) 1634-1639
• 11 Darouiche RO, Wall Jr MJ, Itani KM. et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med 2010; 362 (01) 18-26
• 12 Wade RG, Burr NE, McCauley G, Bourke G, Efthimiou O. The comparative efficacy of chlorhexidine gluconate and povidone-iodine antiseptics for the prevention of infection in clean surgery: a systematic review and network meta-analysis. Ann Surg 2021; 274 (06) e481-e488
• 13 Seiberling KA, McHugh RK, Aruni W, Church CA. The impact of intraoperative saline irrigations on bacterial load within the maxillary sinus. Int Forum Allergy Rhinol 2011; 1 (05) 351-355
• 14 Megow A, Alsuliman Y, Bouras G. et al. Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections. Int Forum Allergy Rhinol 2022; 12 (11) 1362-1376
• 15 Rot P, Szczygielski K, Skrzypiec Ł, Jurkiewicz D. The impact of intraoperative antiseptic nasal irrigation during endoscopic sinus surgery on early postoperative results. Otolaryngol Pol 2021; 75 (04) 27-32
• 16 Little AS, Kshettry VR, Rosen MR. et al. Postoperative oral antibiotics and sinonasal outcomes following endoscopic transsphenoidal surgery for pituitary tumors study: a multicenter, prospective, randomized, double-blinded, placebo-controlled study. Neurosurgery 2021; 89 (05) 769-776
• 17 Conger A, Zhao F, Wang X. et al. Evolution of the graded repair of CSF leaks and skull base defects in endonasal endoscopic tumor surgery: trends in repair failure and meningitis rates in 509 patients. J Neurosurg 2019; 130 (03) 861-875
• 18 Hardesty DA, Montaser A, Kreatsoulas D. et al. Complications after 1002 endoscopic endonasal approach procedures at a single center: lessons learned, 2010-2018. J Neurosurg 2021; 136 (02) 393-404
• 19 Ivan ME, Iorgulescu JB, El-Sayed I. et al. Risk factors for postoperative cerebrospinal fluid leak and meningitis after expanded endoscopic endonasal surgery. J Clin Neurosci 2015; 22 (01) 48-54
• 20 Alsaleh S, Albakr A, Alromaih S, Alatar A, Alroqi AS, Ajlan A. Expanded transnasal approaches to the skull base in the Middle East: where do we stand?. Ann Saudi Med 2020; 40 (02) 94-104